ANI Pharmaceuticals, Inc.: 13 recalls on record

Recalls filed with 1 agency: FDA (13).

First recall on record: October 28, 2020. Most recent: July 1, 2026.

Risk classification: Class II: 6 · Class III: 7

Most recent recalls

DateAgencyProduct
July 1, 2026FDAhydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distr…D-0619-2026
May 27, 2026FDAEstradiol Gel, 0.1%, 0.25 mg, 0.25 g per packet, 30 packets per carton, Rx only, Distribu…D-0543-2026
February 23, 2022FDAAlprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-902-10), b) 5…D-0566-2022
February 23, 2022FDAAlprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-900-10), b) …D-0564-2022
February 23, 2022FDAAlprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-901-10), b) 5…D-0565-2022
February 23, 2022FDAPyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by: ULTRAtab L…D-0568-2022
February 23, 2022FDAAlprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-903-10), b) 5…D-0567-2022
October 28, 2020FDADextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfat…D-0048-2021
October 28, 2020FDADextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfat…D-0044-2021
October 28, 2020FDADextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfat…D-0043-2021
October 28, 2020FDADextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfat…D-0047-2021
October 28, 2020FDADextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfat…D-0045-2021
October 28, 2020FDADextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfat…D-0046-2021

Questions about this company

How many recalls does ANI Pharmaceuticals, Inc. have?
Recalert has 13 U.S. recalls on record for ANI Pharmaceuticals, Inc., published between October 28, 2020 and July 1, 2026.
What was the most recent ANI Pharmaceuticals, Inc. recall?
FDA recall D-0619-2026, published July 1, 2026: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
Which agencies have handled ANI Pharmaceuticals, Inc. recalls?
ANI Pharmaceuticals, Inc. appears as the recalling firm in recalls from: FDA (13).

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